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A study comparing effects of two drugs ie., melatonin and midazolam which are given orally before surgery for relieving anxiety in children undergoing surgery

A comparitive study on effects of oral melatonin versus oral midazolam as premedicant in children undergoing surgery under general anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025698
Enrollment
70
Registered
2020-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L598- Other specified disorders of the skin and subcutaneous tissue related to radiation Health Condition 2: N471- Phimosis Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Melatonin syrup: 0.2mg/kg,orally,single dose Control Intervention1: Midazolam: 0.5mg/kg,orally,single dose

Sponsors

ESIC MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 AND 2 SHEDULED FOR ELECTIVE SURGERY INFORMED WRITTEN CONSENT

Exclusion criteria

Exclusion criteria: 1.ASA 3 AND 4 2.PATIENT WHO HAD TAKEN BENZODIAZEPIINES,OPIOD DRUGS AND OTHER SEDATIVES IN PREVIOUS MONTH 3.PATIENT REFUSAL 4.PATIENT UNDERGOING EMERGENCY SURGERY

Design outcomes

Primary

MeasureTime frame
Sedation and anxiety scores after premedication. Induction dose of propofolTimepoint: Just before premedication. 90 minutes after premedication. Before induction. 10minutes after extubation.—

Secondary

MeasureTime frame
INDUCTION DOSE OF PROPOFOLTimepoint: After loss of eyelash reflex—

Countries

India

Contacts

Public ContactDr GSUNANDA

Esi medical college and hospital

sunanda_gooty@yahoo.com9866999244

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026